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HY1272 in Patients With Locally Advanced or Metastatic Solid Tumors or Locally Advanced or Metastatic EGFRm+ NSCLC

NCT06218940 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-01-23

No results posted yet for this study

Summary

This is a Phase 1, open-label, multicenter, dose escalation study of HY1272 (administered via IV) evaluating both Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) in patients diagnosed with locally advanced or metastatic solid tumors (monotherapy) or locally advanced or metastatic EGFRm+ NSCLC (combination therapy). The study is designed to evaluate safety, tolerability, PK, and anti-tumor activity of HY1272 administered once weekly. Patients in the monotherapy portion of this study will receive only HY1272. Patients in the combination therapy portion of this study will receive osimertinib administered once daily (QD) with HY1272.

Conditions

  • NSCLC Stage IV

Interventions

DRUG

HY1272

Each patient will receive HY1272 weely or HY1272 weely+Oshitinib 80mg P.O. daily

Sponsors & Collaborators

  • Newsoara Biopharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hannah Chen · Sponsor GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-12-01
Completion
2027-12-01
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06218940 on ClinicalTrials.gov